New treatment of acute hypoxemic respiratory failure: noninvasive pressure support ventilation delivered by helmet--a pilot controlled trial.

OBJECTIVE: To assess the efficacy of noninvasive pressure support ventilation (NPSV) using a new special helmet as first-line intervention to treat patients with hypoxemic acute respiratory failure (ARF), in comparison to NPSV using standard facial mask.

DESIGN AND SETTING: Prospective clinical pilot investigation with matched control group in three intensive care units of university hospitals.

PATIENTS AND METHODS: Thirty-three consecutive patients without chronic obstructive pulmonary disease and with hypoxemic ARF (defined as severe dyspnea at rest, respiratory rate >30 breaths/min, PaO2:FiO2 < 200, and active contraction of the accessory muscles of respiration) were enrolled. Each patient treated with NPSV by helmet was matched with two controls with ARF treated with NPSV via a facial mask, selected by simplified acute physiologic score II, age, PaO2/FiO2, and arterial pH at admission. Primary end points were the improvement of gas exchanges, the need for endotracheal intubation, and the complications related to NPSV.

RESULTS: The 33 patients and the 66 controls had similar characteristics at baseline. Both groups improved oxygenation after NPSV. Eight patients (24%) in the helmet group and 21 patients (32%) in the facial mask group (p = .3) failed NPSV and were intubated. No patients failed NPSV because of intolerance of the technique in the helmet group in comparison with 8 patients (38%) in the mask group (p = .047). Complications related to the technique (skin necrosis, gastric distension, and eye irritation) were fewer in the helmet group compared with the mask group (no patients vs. 14 patients (21%), p = .002). The helmet allowed the continuous application of NPSV for a longer period of time (p = .05). Length of stay in the intensive care unit, intensive care, and hospital mortality were not different.

CONCLUSIONS: NPSV by helmet successfully treated hypoxemic ARF, with better tolerance and fewer complications than facial mask NPSV.